BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2053286 · Received April 13, 2011

    Report

    Report Number
    2183613-2011-00088
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 3, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S70
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EPG (EXTERNAL PULSE GENERATOR) WAS ATTACHED TO A PATIENT WHEN THE HOSPITAL STAFF FOUND THAT IT HAD STOPPED. IT WAS FURTHER NOTED THAT THE BATTERY SPECIFIED BY MEDTRONIC (B)(6) WAS NOT USED. THE TERMINAL OF THE BATTERY USED HAD A PLASTIC RING COVER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT HAD THEIR OWN INTRINSIC RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5348 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other